FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB)

TO THE NATIONAL ORGANIC PROGRAM (NOP)

Date: 11-05-09

Subject: Excipients

Chair: Jeff Moyer

Recommendation

The NOSB hereby recommends to the NOP the following:

Rulemaking Action: ___ __

Guidance Statement: ________

Other: Material Annotation Technical Corrections & Clarifications

Summary Statement of the Recommendation (including Recount of Vote):

This recommendation proposes to correct some key oversights when the original recommendation 

for (f) was written. The topic of excipients is simultaneously vague and hair-splitting while 

incredibly important to certified organic livestock producers since few formulated livestock 

products are without excipients. This recommendation proposes to clear up misconceptions and 

the wide divergence of certifier interpretations that currently exist regarding excipients.

NOSB Vote: Motion: Hubert Karreman Second: Tina Ellor

Board vote: Yes - 13 No- 0 Abstain- 0 Absent - 2 

Summary Rationale Supporting Recommendation (including consistency with OFPA and 

NOP):

7CFR238(a)(6)

7CFR238(c)(2)

7CFR238(c)(7)

7CFR603(a)(4)

Also, in an e-mail from OGC (via NOP) on March 24, 2009, it was stated: "In terms of the board 

recommending a substance to be added to the national list without a petition, (An OGC person 

sees) nothing in the OFPA or NOP regulations that would prohibit such action. (Another OGC 

person) agrees as well, and indicated that he believes the original NL was created by the board 

without any petitions. In either event, it would seem like the board's primary function is to make 

recommendations concerning the NL (to add, remove, renew, etc.) and that petitions are just one 

mechanism through which the board can make such recommendations."

Response by the NOP:
National Organic Standards Board (NOSB)

Livestock Committee

RECOMMENDATION TO CHANGE 205.603 (f):

Current 205.603(f):

(f) Excipients, only for use in the manufacture of drugs used to treat organic livestock 

when the excipient is: Identified by the FDA as Generally Recognized As Safe; 

Approved by the FDA as a food additive; or Included in the FDA review and approval of 

a New Animal Drug Application or New Drug Application.

I. Introduction: 

This recommendation proposes to correct some key oversights when the original 

recommendation for (f) was written. The topic of excipients is simultaneously vague and 

hair-splitting while incredibly important to certified organic livestock producers since few 

formulated livestock products are without excipients. This recommendation proposes to 

clear up misconceptions and the wide divergence of certifier interpretations that currently 

exist regarding excipients. 

II. Background: 

Prior to the 12/17/07 Federal Register notice which added section (f) to the National List 

at 205.603, no excipients were officially allowed. Certifiers decided to allow formulated 

products on a case by case basis, often basing decisions on the acceptability of the 

product’s excipients (preservatives, stabilizers, etc). Upon addition of section (f) to 

205.603, clearly prescriptive language helped certifiers review excipients. However, two 

points quickly came to the attention of anyone who is interested in the review process of 

livestock products: (1) the excipients clause (f) only applies to drugs and (2) there was 

no mention of APHIS approved excipients which are commonly used with vaccines and 

biologics. These two points are very problematic. Certified organic producers are not 

allowed to use drugs in the absence of illness – however, almost all farmers will give 

animal health care products of various types even though the animal is obviously not ill 

i.e. injectable vitamins or trace mineral formulations may be used in times of stress, and 

these all have excipients. Additionally, it was an honest oversight in the original writing 

of (f) to not state that APHIS approved excipients were to be allowed. The most likely 

reason is that the petitioned materials at the time were all under FDA oversight and not 

APHIS oversight. That excipients in formulated biologics under APHIS oversight were 

also intended to be covered by section (f) but unfortunately forgotten during that long 

process is regrettable.

III. Relevant areas in the Rule: 
§ 205.238 Livestock health care practice standard.

(c) The producer of an organic livestock operation must not:

(2) Administer any animal drug, other than vaccinations, in the absence of illness;

In the section 238(c) (2) above, it states clearly that drugs cannot be administered in the 

absence of illness. One could argue the definition of “illness” – is it only when diagnosed 

by a licensed medical professional (who has legal rights to prescribe drugs)? Or are 

there other conditions which also hinder the health of animals that producers can identify 

simply by being the primary care attendant. The answer is Yes. However, it is only drugs 

which are referred to in the current excipient language. Therefore, when a farmer would 

like to use an oral digestive enhancement or rub on a simple peppermint liniment for the 

udder – which have excipients – it is currently not allowed. An animal thus treated could 

be directed by a certifier at this time to be permanently removed from certified organic 

production. 

(7) Withhold medical treatment from a sick animal in an effort to preserve its organic 

status. All appropriate medications must be used to restore an animal to health when 

methods acceptable to organic production fail. Livestock treated with a prohibited 

substance must be clearly identified and shall not be sold, labeled, or represented as 

organically produced.

In the section 238 (c) (7) above, the term “medical treatment” does not necessarily 

dictate “drug” as used in the excipients section. Indeed, it goes on to say “all appropriate 

medications” must be used to restore an animal to health. While people steeped in 

conventional thought would quickly think of standard drugs (as referred to in section (f) 

as it is currently written, most organic livestock producers and organic health care 

providers may view medical treatments and medications in a wider context to include 

complementary and alternative veterinary medicines such as botanical derivatives, 

homeopathic remedies, injectable nutritives, etc. All these, like “standard” medications, 

are stabilized or emulsified, etc with the use of excipients.

§ 205.238 Livestock health care practice standard.

(a) The producer must establish and maintain preventive livestock health care practices, 

including:

(6) Administration of vaccines and other veterinary biologics.

Clearly, vaccines and biologics are encouraged for preventive livestock health care. 

However, as the current section (f) is written, there is no allowance for the excipients 

which are universally used with vaccines and biologics. In order to properly enable 

238(a)(6), excipients associated with vaccines and biologics need to be explicitly 

addressed in the positive.

§205.603 Synthetic substances allowed for use in organic livestock production. 

In accordance with restrictions specified in this section the following synthetic 

substances may be used in organic livestock production: 

(a) As disinfectants, sanitizer, and medical treatments as applicable.

(4) Biologics--Vaccines.
Again, biologics and vaccines are specifically mentioned as being allowed by 205.603. 

However, this section is the list of synthetics allowed and pertains only to synthetic 

vaccines and biologics. There are many, many more vaccines and biologics which are 

not synthetic, such as colostrum whey products, which are widely used by organic 

livestock producers. Such natural biologics and vaccines, while addressed in a generic 

sense in 205.238(a)(6), are allowed in organic livestock production unless prohibited in 

§205.604, and also need to be covered for their potential excipients as well. This 

proposal would accomplish that. 

IV. Discussion: 

The intent of this recommendation is to help farmers take the best care of their livestock 

without reverting to prohibited materials. Many widely embraced and time honored 

animal health care products that enable farmers to help keep animals healthy contain 

excipients. Unfortunately it is the excipients, especially as stated under the current 

section (f), that place many popular animal health care products in peril of being 

prohibited even though they have been allowed previously. This recommendation will 

help reviewers be aware that it is the active ingredients of products under review that 

need the most attention and that the excipients, if allowed by the categories as stated by 

the proposed recommendation, should not be the deciding factor in whether or not an 

animal health care product can be utilized by farmers who provide the daily care to their 

animals. This recommendation also helps clarify and codify what the NOP had intended 

regarding excipients that APHIS allows for vaccines and biologics. It is acknowledged 

that there are many excipients that will be allowed for animal health care products; 

however, as currently written (limiting excipients to drugs with only FDA recognized 

substances), there already are many allowed. It is worth mentioning that excipients are 

inert ingredients added to a formulation to help the active ingredient perform more 

effectively. This recommendation will make it clear that all animal health care products 

(not just drugs) shall be protected from undue focus regarding their associated 

excipients. 

V. Recommendation: 

The Livestock Committee recommends the following change to the regulation:

§205.603(f) Excipients, only for use in the manufacture of animal health care products

used to treat organic livestock when the excipient is: Identified by the FDA as Generally 

Recognized As Safe; Approved by the FDA as a food additive; Included in the FDA 

review and approval of a New Animal Drug Application or New Drug Application; or 

approved by APHIS.

VI. Committee Vote: 

Motion: Dan Giacomini

Second: Hubert Karreman

Committee Vote: Yes: 7 No: 0 Abstain Absent: